Folic Acid

ANDA 80600, held by Hikma. Folic Acid.

As of Nov 15, 2026, ANDA 80600 (Folic Acid), held by Hikma, was first approved by FDA on Mar 31, 1972, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1972
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 31, 1972	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Folic Acid1MG · tablet;oral	Folic Acid	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Feb 17, 2000	Supplement 31Manufacturing	Approved	None posted
May 13, 1999	Supplement 29Manufacturing	Approved	None posted
May 13, 1999	Supplement 30Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 28Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 25Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 26Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 27Labeling	Approved	None posted
Jun 19, 1997	Supplement 24Manufacturing	Approved	None posted
Apr 24, 1995	Supplement 23Labeling	Approved	None posted
Jul 29, 1994	Supplement 21Manufacturing	Approved	None posted
Jul 29, 1994	Supplement 22Labeling	Approved	None posted
Jul 29, 1993	Supplement 20Manufacturing	Approved	None posted
Jun 28, 1993	Supplement 19Labeling	Approved	None posted
Jun 28, 1993	Supplement 40Labeling	Approved	None posted
Jul 17, 1989	Supplement 14Labeling	Approved	None posted
Oct 1, 1987	Supplement 13Manufacturing	Approved	None posted
Aug 24, 1987	Supplement 12Manufacturing	Approved	None posted
May 31, 1984	Supplement 10Manufacturing	Approved	None posted
Mar 17, 1983	Supplement 6Manufacturing	Approved	None posted
Mar 31, 1972	Original application	Approved	Review

Identifiers

Application: ANDA 80600
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters